JP7418320B2 - Catheter for directing body fluids - Google Patents

Description

[0001] This application claims priority to U.S. Provisional Patent Application No. 62/483,483, filed April 10, 2017, which is incorporated by reference in its entirety.

[0002] The present invention relates to a medical catheter, and particularly to a medical catheter for guiding body fluids such as urine.

[0003] Urinary retention is the inability to empty the bladder. Urinary retention is a common and serious problem resulting from a variety of causes, one of which is aging. Urinary retention in men can also be caused by urethral obstruction, neurological problems, inappropriate drug therapy, and weakened bladder muscles.

[0004] An obstruction occurs when the free flow of urine through the urinary tract is blocked. Common causes of obstructive urinary retention include benign prostatic hyperplasia (BPH), urethral strictures, kidney stones or bladder stones, etc. In non-obstructive urinary retention (eg, weakened bladder muscles, inadequate medication, neurological problems, etc.), signals between the brain and the bladder are disrupted. Common causes of non-obstructive urinary retention include stroke, pelvic injury, wound, neurological disease, muscle injury, neurological dysfunction due to medication, paralysis, and accidents that damage the brain or spinal cord.

[0005] Studies have shown that for every 1000 men between the ages of 40 and 83, the probability of developing urinary retention is 4.5 to 6.8. Specifically, for men in their 70s, the overall incidence increases to 100 out of 1000. In people in their 80s, the incidence of acute urinary retention increases to 300/1000. Patients with acute or chronic urinary retention develop a variety of symptoms. Patients with acute urinary retention have symptoms such as inability to urinate, pain or sudden urge to urinate, sudden pain or discomfort in the lower abdomen, and bloating in the lower abdomen. Prompt treatment is required.

[0006] Treatment methods for urinary retention include catheterization, urethral dilation, urethral stents, prostate-specific drug therapy, surgery, and the like. However, these treatments are not always suitable for all patients. For example, catheterization is the only option for patients with neurological urinary retention. Current catheterization methods include Foley catheters (urinary catheters), suprapubic drainage tubes, or intermittent catheterization.

[0007] Foley catheters (ie, indwelling catheters) include two bipartite passageways or lumens running along their length. One of the passages has openings at both ends and is for draining urine into the collection pack. The other passageway has a valve at its outer end and a balloon at its inner end. Once the balloon is placed in the bladder, it fills with sterile water and acts as an anchor to prevent the catheter from slipping out. However, Foley catheters have multiple drawbacks such as crust formation, blockage, structural damage to the urethra and bladder, promotion of bladder or kidney stone formation, and infections (e.g., urinary tract infections (UTIs), renal pelvic infections, and blood infections). has.

[0008] Compared to Foley catheters, suprapubic catheters have a lower risk of urethral injury or stenosis. However, it can cause upper urinary tract injury, vesicoureteral reflux, kidney or bladder stones, and urinary tract infections.

[0009] Intermittent urinary catheterization involves insertion and removal of a catheter several times a day to empty the bladder and reduces the need for long-term indwelling catheters. However, intermittent catheterization involves patient admission and manual handling. Intermittent catheterization requires approximately 20 minutes to complete the entire procedure, ie, each catheter insertion or removal. It is very inconvenient for the patient and often adds to the embarrassment when the procedure is performed away from home. Furthermore, patients with spinal cord injuries may develop epididymitis (incidence of approximately 28%), urethritis (incidence of approximately 18%), and prostatitis (incidence of approximately 33%) due to intermittent catheterization. It is reported that.

[0010] Thus, conventional treatments/devices have very high infection rates and are also inconvenient for patients and medical staff. As a result, patients with urinary retention feel uncomfortable and refrain from participating in social activities, leading to a decline in their quality of life.

[0011] To overcome the above-mentioned problems, US Pat. No. 7,547,291 discloses a device for reducing urinary retention (ie, an artificial urethra). The device includes first and second tubular elements and a bridge segment sandwiched therebetween. The first tubular element further includes a drainage hole, a passageway for fluid flow, and an inflatable balloon for maintaining the position of the artificial urethra. Additionally, the device includes a valve disposed on the second tubular element to control urine flow. The device does not require external tubes or collection bags. The patient can also actively control the device to empty his/her bladder. However, because the balloon is placed near the tubular tip, urine may not be completely expelled. This causes urine to remain in the bladder, which over time can cause inflammation and lead to bladder infections. Similar designs of such devices are disclosed in US Pat. No. 6,835,183;

[0012] U.S. Patent Application Publication No. 20160015936 and U.S. Patent No. 9,011,314 disclose a urinary flow control system (ie, the CymActive ^™ system). The system can be placed or held in the bladder and urethra, passing through the two sphincter muscles. Specifically, the system utilizes a Marcoux anchor to maintain its position within the bladder. The system includes a magnetic valve at the distal end, and the patient can control the opening and closing of the valve by an actuator magnet. The system is self-retaining and can fill and empty the bladder periodically without external equipment. Marcoux anchors can also be used to improve evacuation. However, magnetic valves can cause patient discomfort due to their size. Also, the patient must carry the actuator magnet with him at all times. Without the actuator magnet, too much urine can accumulate, leading to increased pressure in the kidney. This can cause kidney failure or permanently damage the kidneys. Similar designs of magnetically actuated urethral valves are disclosed in US Pat. No. 6,234,956 and US Pat. No. 5,030,199.

[0013] US Pat. No. 8,137,337 discloses an indwelling urinary catheter with a self-retention mechanism. The self-retention mechanism of the catheter is actuated by an actuation linkage to control the catheter between an "open" state and a "closed state." Therefore, no additional fixation elements are required to prevent the catheter from being inadvertently withdrawn from the patient. Furthermore, the self-retention mechanism results in continuous emptying of the bladder, which may reduce the likelihood of urine retention and infection. Although the catheter provides an improved retention mechanism that facilitates catheter introduction and removal, it still has some drawbacks. For example, the material of the actuation mechanism should be a hard, rigid plastic such as PP (polypropylene), PE (polyethylene), or PC (polycarbonate) in order to provide sufficient force to keep the catheter open. . However, these materials tend to cause discomfort and pain to the patient.

[0014] US Pat. No. 6,589,208 discloses a self-expanding catheter assembly. The main structure of the catheter assembly includes a fixation device attached to the tube. The fixation device automatically maintains the tube shape with the ends spaced apart while being inserted into the body cavity, and transforms into a mushroom shape when the catheter is fully inserted into the body cavity, and the tube remains in the body cavity. It is slightly pulled out of the body cavity. The catheter also includes a suture designed to be releasable from the distal end of the anchor to promote tubular shape. However, the entry point of the catheter is at the end of the anchor, which is not placed at the base of the bladder when the catheter is placed. As a result, the urine in the bladder is not completely emptied, which can lead to bladder inflammation and infection. Additionally, the user needs to use the wire to control whether the anchor is deformed into a mushroom shape. In other words, such additional elements are required on the catheter to maintain the mushroom shape of the anchor. Such additional parts increase the difficulty in the manufacturing process and make handling difficult. Basically, the aforementioned is materially similar to the Lotus catheter and therefore has similar drawbacks.

[0015] An object of the present invention is to provide a device that properly drains the bladder while being easy to operate. The device not only reduces the potential for complications, but also allows for easier donning and doffing.

[0016] The present disclosure provides a catheter for directing bodily fluids in a subject. The catheter includes an elongate body having a proximal tip and a distal tip and an adjustment mechanism having two opposite ends. In one aspect, the catheter includes a first portion, a second portion, and a flexible portion between the first and second portions. The second portion includes a peripheral wall defining a passageway for bodily fluids, the passageway further including an inlet and an outlet. In another aspect, a first end of the adjustment mechanism connects the first portion of the catheter and a second end of the adjustment mechanism engages the second portion of the catheter proximal to the entrance of the passageway. The adjustment mechanism is adapted to change according to different conditions. Furthermore, when the adjustment mechanism is in the first state, the flexible portion of the catheter expands to secure the catheter within the subject, and when the flexible portion is retracted, the adjustment mechanism changes to a second state, thereby allows insertion of a catheter into/removal of a catheter from a subject. Body fluids are also directed to enter the passageway via the second section inlet and exit via the second section outlet.

[0017] In some embodiments, the first portion of the elongated body includes a compartment and the adjustment mechanism further includes a biasing element near the first end. Additionally, a biasing device is housed within the compartment.

[0018] In some embodiments, the biasing device is compressed in the second state.

[0019] In some embodiments, the adjustment mechanism is extended in the second state.

[0020] In some embodiments, the second end of the adjustment mechanism does not obstruct the passageway.

[0021] In certain embodiments, the catheter includes a withdrawal wire connected to the second portion, the withdrawal wire extending outside the subject and can be easily withdrawn to remove the catheter. .

[0022] In some embodiments, the length of the second portion is about 4 cm to 6 cm.

[0023] In some embodiments, the second end of the adjustment mechanism includes a first valve mechanism proximal to the entrance of the passageway, and when the first valve mechanism is opened, body fluid enters the passageway through the entrance; Body fluids may be prevented from entering the passageway when the first valve mechanism is closed.

[0024] In some embodiments, the first portion of the elongated body further includes a compartment and the adjustment mechanism includes a biasing element proximate the first end. Furthermore, the biasing element is housed within the compartment.

[0025] In some embodiments, the length of the second portion is about 7 cm to 10 cm.

[0026] In some embodiments, the adjustment mechanism includes a control wire configured to open and close the first valve mechanism.

[0027] In some embodiments, the flexible portion further includes a flexible portion such that the flexible portion and the first portion are more securely secured within the subject when the control wire is pulled to open the first valve mechanism. Expand.

[0028] In some embodiments, the catheter further includes a locking module and a second valve mechanism. A locking module is also housed within the first portion of the catheter and engages the adjustment mechanism. A second valve mechanism is at the distal end of the control wire to control bodily fluids to exit the passageway via the outlet. Additionally, the locking module controls opening and closing of the inlet when the adjustment mechanism is not in the second state.

[0029] In some embodiments, the length of the second portion is about 15 cm to 20 cm.

[0030] In some embodiments, the exit of the passageway is external to the subject.

[0031] In some embodiments, the flexible portion comprises at least two arms.

[0032] In certain embodiments, the catheter material comprises polyvinyl chloride (PVC), silicone , thermoplastic polyurethane (TPU), thermoplastic rubber (TPR), or any combination thereof.

[0033] In some embodiments, only the first portion and the flexible portion are disposed within the subject's lumen when the catheter is not in the second state.

[0034] In certain embodiments, the lumen is defined by the bladder.

[0035] The present invention provides a catheter for guiding body fluids in a subject. The catheter includes an elongate body having a proximal tip and a distal tip, an adjustment mechanism having a first end and an opposite second end, and a valve mechanism at the second end of the adjustment mechanism. In one aspect, the elongate body further includes a first portion, a second portion, and a flexible portion between the first and second portions. The portion includes a peripheral wall that defines a passageway for body fluids. The passageway further includes an inlet and an outlet. In another aspect, the first end of the adjustment mechanism engages the first portion of the catheter. A valve mechanism engages the second portion proximal to the entrance to the passageway. Body fluids can enter the passageway via the inlet when the valve mechanism is opened, and body fluids can be prevented from entering the passageway when the valve mechanism is closed. Specifically, the adjustment mechanism is in the first state when the flexible portion expands to secure the catheter within the subject, and the flexible portion retracts to insert the catheter into or from the subject. The adjustment mechanism changes to the second state when allowing removal of the catheter. Body fluids are thus directed to enter the passageway via the inlet of the second part and exit via the outlet of the second part.

[0036] In the accompanying drawings, one or more embodiments are illustrated by way of example and not by way of limitation, and elements having the same reference numerals represent similar elements. The drawings are not to scale unless otherwise disclosed.

1 is a schematic diagram of a catheter for directing bodily fluids without a valve mechanism placed at a precise location within the bladder, according to some embodiments of the present disclosure; FIG. 1 is a cross-sectional view of a catheter for directing bodily fluids without a valve mechanism placed at a precise location within a bladder, according to some embodiments of the present disclosure; FIG. The catheter is shown to be deformed when the adjustment mechanism is in the first state. 1 is a cross-sectional view of a catheter for directing bodily fluids without a valve mechanism placed at a precise location within a bladder, according to some embodiments of the present disclosure; FIG. FIG. 3 is a cross-sectional view taken along line A-A'. 1 is a cross-sectional view of a catheter for directing bodily fluids without a valve mechanism placed at a precise location within a bladder, according to some embodiments of the present disclosure; FIG. The catheter is shown in a tubular shape when the adjustment mechanism is in the second state. 1 is a cross-sectional view of a catheter having a valve mechanism for controlling body fluid flow, according to some embodiments of the present disclosure. FIG. The catheter is shown deformed to close the valve mechanism when the adjustment mechanism is in the first state. 1 is a cross-sectional view of a catheter having a valve mechanism for controlling body fluid flow, according to some embodiments of the present disclosure. FIG. The catheter is shown in a tubular shape when the adjustment mechanism is in the second state. 1 is a cross-sectional view of a catheter having a valve mechanism for controlling body fluid flow, according to some embodiments of the present disclosure. FIG. The catheter is deformed to further indicate that the valve mechanism is open when the adjustment mechanism is neither in the first nor second condition. FIG. 3 is a cross-sectional view of another catheter having different adjustment mechanisms and valve mechanisms for controlling body fluid flow, according to some embodiments of the present disclosure. The catheter is shown deformed to close the valve mechanism when the adjustment mechanism is in the first state. FIG. 3 is a cross-sectional view of another catheter having different adjustment mechanisms and valve mechanisms for controlling body fluid flow, according to some embodiments of the present disclosure. The catheter is shown in a tubular shape when the adjustment mechanism is in the second state. FIG. 3 is a cross-sectional view of another catheter having different adjustment mechanisms and valve mechanisms for controlling body fluid flow, according to some embodiments of the present disclosure. The catheter is deformed to further indicate that the valve mechanism is open when the adjustment mechanism is neither in the first nor second condition. In accordance with some embodiments of the present disclosure, a catheter having a locking module and two valve mechanisms for controlling body fluid flow is placed at a precise location within the bladder and outside the body mass. FIG. 3 is a schematic diagram showing a portion of the catheter extending to the front end of the catheter. 1 is a cross-sectional view of a catheter having a locking module and a valve mechanism for controlling body fluid flow, according to some embodiments of the present disclosure. FIG. 1 is a cross-sectional view of a catheter having a locking module and a valve mechanism for controlling body fluid flow, according to some embodiments of the present disclosure. FIG. 1 is a cross-sectional view of a catheter having a locking module and a valve mechanism for controlling body fluid flow, according to some embodiments of the present disclosure. FIG. 1 is a cross-sectional view of a catheter having a locking module and a valve mechanism for controlling body fluid flow, according to some embodiments of the present disclosure. FIG.

[0043] The drawings are for illustrative purposes only and are non-limiting. In the drawings, the size of some of the components may be exaggerated and not drawn on scale for illustrative purposes. Dimensions and relative dimensions do not necessarily correspond to statutory implementation of the invention. Any reference signs in the claims shall not be construed as limiting the scope. Like reference numerals in the various drawings indicate like elements.

[0044] Formation and use of embodiments of the present disclosure are described in detail below. However, it should be understood that the embodiments provide many applicable inventive concepts that may be embodied in a variety of specific contexts. The particular embodiments discussed are merely illustrative of particular ways to make and use the embodiments and do not limit the scope of the disclosure.

[0045] Like reference numerals are used to represent like components throughout the figures and illustrated embodiments. Reference will now be made to the exemplary embodiments illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used in the drawings and the description to refer to the same or similar parts. In the drawings, shapes and thickness may be exaggerated for clarity and convenience. This description particularly relates to components forming part of, or cooperating more directly with, the apparatus according to the present disclosure. It can be understood that components not specifically shown or depicted may take various forms. Throughout this specification, references to "an embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in that embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner in one or more embodiments. It can be understood that the following drawings are not drawn to scale and that these drawings are for illustrative purposes only.

definition
[0046] When a component is referred to as being "on" another component, it is intended that the component may be directly on top of the other component, or there may be intervening components. will be understood. In contrast, when a component is referred to as being "directly on" another component, there are no intervening components.

[0047] It will be understood that the singular forms "a," "an," and "the" are intended to include the plural forms, unless explicitly stated otherwise.

[0048] "About" as used herein, for example, when referring to a measurable numerical value such as quantity, duration, etc., refers to a variation of ±5%, more preferably a variation of ±1%, from a specific numerical value. and such variations are appropriate for carrying out the disclosed method.

[0049] Unless defined otherwise, all terms (including scientific and technical terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. There is. Furthermore, terms as defined in common dictionaries should be construed to have meanings consistent with their meanings in the relevant fields and in relation to this disclosure, and not expressly defined herein. insofar as it is not to be construed in an ideal or overly formal sense.

detailed description
[0050] The present disclosure provides a catheter that can be placed within a patient's body to assist in urination. FIG. 1 is a schematic diagram illustrating a catheter 10 (ie, frame) without a valve mechanism for directing body fluids (eg, urine 55) placed in a precise location within a bladder 50. As shown, only the second portion 104 of the catheter 10 passes through the prostate 52 (i.e., the second only part is placed within the urethra 51). Additionally, when the catheter 10 is in its normal state, the flexible portion 106 of the catheter 10 is deployed and acts as an anchor to maintain the catheter 10 in the correct position. Thus, urine 55 within bladder 50 is drained through second portion 104 of catheter 10.

[0051] FIG. 2 includes three cross-sectional views (FIGS. 2A-2C) showing a catheter 10 without a valve mechanism for directing body fluids. As shown in FIG. 2A, the catheter 10 includes an elongated body having a proximal tip and a distal tip, and an adjustment mechanism 108 having two opposite ends (i.e., a first end 1084 and a second end 1086). Be prepared. Additionally, the elongated body of catheter 10 includes a first portion 102, a second portion 104, and a flexible portion 106 located between the first and second portions. The second portion 104 includes a peripheral wall defining a passageway 1046 for the flow of bodily fluids, and the passageway 1046 further includes an inlet 1042 and an outlet 1044. In some embodiments, second portion 104 may further include a withdrawal wire 112 that connects to second portion 104 near outlet 1044 for removal of catheter 10 by a user. Additionally, the inlet 1042 of the second portion 104 further includes a sheath 1048. In another aspect, a first end 1084 of the adjustment mechanism 108 is secured to the first portion 102 of the catheter 10 and a second end 1086 of the adjustment mechanism 108 is secured to the sheath of the second portion 104 near the entrance 1042 of the passageway 1046. 1048. Adjustment mechanism 108 may be formed by a biasing element (eg, a spring) or an elastic element (eg, an elastic wire). The length of adjustment mechanism 108 changes when compressed or expanded from its rest, equilibrium position. When the adjustment mechanism 108 is at rest (i.e., at equilibrium), that is, when the adjustment mechanism 108 is at its initial length with no tension or compression forces applied to it, the flexible portion 106 is expanded. , allowing the catheter to be secured within the body cavity. When the adjustment mechanism 108 is extended (lengthening the adjustment mechanism 108), the flexible portion 106 can be retracted to change the catheter 10 into a tubular shape. When adjustment mechanism 108 is compressed (shortening adjustment mechanism 108), flexible portion 106 expands to ensure that the catheter cannot be easily removed from within the body cavity. According to the present disclosure, adjustment mechanism 108 is adapted to change to different states, ie, change length, to accommodate expansion or retraction of flexible portion 106.

[0052] When adjustment mechanism 108 is at rest (ie, at an initial length), adjustment mechanism 108 is defined as being in a first state. In the first state, flexible portion 106 of catheter 10 is expanded and acts as an anchor to maintain catheter 10 within the subject's body cavity. When the catheter 10 is properly placed, the inlet 1042 of the catheter 10 is at or near the bottom of the body cavity, allowing the body fluids within the body cavity to be completely drained.

[0053] FIG. 2B is a cross-sectional view of the inlet of the second portion 104 of FIG. 2A along line A-A'. The structure of the second end 1086 of the adjustment mechanism (not shown) is ring-shaped or any similar shape that does not obstruct the flow of bodily fluids into the passageway 1046.

[0054] Figure 2C shows catheter 10 in a tubular configuration, ie, flexible portion 106 is retracted. When catheter 10 is in this tubular configuration, adjustment mechanism 108 is defined as being in an expanded second state. When a user removes catheter 10, the user pulls on withdrawal wire 112 to remove catheter 10 from the subject's body cavity. Pull wire 112 is configured to be attached at or near the end of the second portion. When the user pulls on the withdrawal wire 112 to remove the catheter, the muscles surrounding the urethra retract the flexible portion and extend the adjustment mechanism, causing the catheter 10 to become tubular. In other words, when the adjustment mechanism changes to the second state, the flexible portion retracts allowing the catheter to be removed from the subject.

[0055] In another aspect, when a user attempts to insert catheter 10 into a body cavity of a subject, the user retracts flexible portion 106 to move catheter 10 into a tubular configuration for easy insertion. I hope you will. The user extends the adjustment mechanism 108 by applying a direct force to the flexible portion and retracting the flexible portion. First portion 102 and flexible portion 106 of catheter 10 are inserted into a body cavity, and the restoring force of adjustment mechanism 108 causes it to return to its rest position and expand flexible portion 106.

[0056] It should be noted that each of the elements of the flexible portion (ie, only the flexible portion) is in a retracted state when no external force is applied. In some embodiments, the flexible portion extends continuously longitudinally when not subjected to a force. In this situation, the catheter is easily removable from the body cavity, as the flexible portion does not provide an obstructing function. As a result, when the catheter is not removed from the body lumen (ie, when the catheter is not in the second state), a force is applied through the adjustment mechanism to deform the flexible portion. Specifically, the flexible portion takes the form of a cage and acts as a shield to prevent extraction of the catheter from the body cavity. Furthermore, the flexible portion may include at least two flexible arms, preferably the number of flexible arms is three. Catheter 10 maintains a passage through the subject's prostate, and the preferred length of the second portion of catheter 10 is approximately 4 cm to 6 cm.

[0057] The present disclosure also provides other catheters for draining bodily fluids, allowing the user of such catheters to control whether urine is drained from a subject.

[0058] FIG. 3A discloses the catheter 20 with the first valve mechanism 2082 closed when the adjustment mechanism 208 is in the rest position (ie, the first state). As shown in FIG. 3A, the catheter 20 has a first portion 202, a second portion 204, a flexible portion 206, and an adjustment mechanism 208, with the second portion 204 having two opposite has an inlet 2042 and an outlet 2044 at the ends thereof, a sheath 2048 near the inlet 2042, and a passageway 2046. Catheter 20 further includes a first valve mechanism 2082 at the second end of adjustment mechanism 208 and a control wire 210 connected to first valve mechanism 2082 and extending outside the subject's body. A first valve mechanism 2082 is slidably housed within passageway 2046 and removably engaged with sheath 2048. As previously discussed, after a user inserts tubular catheter 20 into a body cavity, the restoring force of adjustment mechanism 208 guides flexible portion 206 to expand, thereby properly securing catheter 20 within the body cavity. be done. FIG. 3A shows catheter 20 with flexible portion 206 (eg, three flexible arms) in an expanded state and adjustment mechanism 208 in a first state. Additionally, a first valve mechanism 2082 (eg, a spherical valve) is engaged with the sheath 2048 and blocks the inlet 2042 to prevent bodily fluids from flowing into the passageway 2046. In other words, the restoring force of the adjustment mechanism 208 helps the first valve mechanism 2082 more securely engage the sheath 2048 and block the inlet 2042.

[0059] FIG. 3B shows the tube-shaped catheter 20 when the adjustment mechanism 208 is in the second state. As previously discussed, a user can retract the flexible arms of flexible portion 206 to tubularize catheter 20, thereby facilitating insertion into or removal from a body cavity. can. In some embodiments, catheter 20 may further include a withdrawal wire 212 that can facilitate removal of catheter 20.

[0060] FIG. 3C discloses the catheter 20 with the first valve mechanism 2082 open when the adjustment mechanism 208 is not in the first and second states. When a user needs to drain body fluids (e.g., urine), the user can simply pull control wire 210 to separate first valve mechanism 2082 from sheath 2048 (i.e., to open inlet 2042). release). Specifically, first valve mechanism 2082 moves away from sheath 2048 when the pulling force applied by the user to control wire 210 is greater than the restoring force of adjustment mechanism 208 .

[0061] Furthermore, if the user continues to pull the control wire 210 after the adjustment mechanism has been extended to its maximum length, the pulling force of the control wire 210 shifts the position of the adjustment mechanism 208 to a position opposite to the catheter 20. let Since the first end 2084 is fixed to the first portion 202, shifting of the adjustment mechanism 208 reduces the distance between the first end 2084 and the inlet 2042. Accordingly, the flexible portion 206 expands further, further increasing the diameter of the cage formed in the flexible arm. Such a structure better secures the first portion 202 and the three flexible arms (ie, flexible portions 206) within the body cavity. If the user wishes to close the inlet 2042, the user simply releases the control wire 210 and the adjustment mechanism 208 returns the catheter 20 to the state shown in FIG. 3A.

[0062] In one aspect, the number of flexible arms is at least two, preferably three. In another aspect, adjustment mechanism 208 may be formed from a spring or resilient wire. Additionally, the length of second portion 204 of catheter 20 is approximately 7 cm to 10 cm.

[0063] FIG. 4 further discloses another catheter 30 having a first valve mechanism 3082. The difference between catheter 30 and the catheters described above is the structure of the adjustment mechanism. FIG. 4A shows the catheter 30 with the first valve mechanism 3082 closed when the adjustment mechanism is in the first state. As shown in FIG. 4A, the adjustment mechanism includes a biasing element 3088 (eg, a spring) and a connecting wire 3090. Additionally, the first portion 302 of the catheter 30 has a compartment 3092 for housing the biasing element 3088 and a portion of the connecting wire 3090. When the biasing element 3088 has a maximum length within the compartment 3092, the biasing element 3088 is defined as being in a first state (i.e., an initial state), where the biasing element 3088 sheaths the first valve mechanism 3082. 3048 to close the inlet 3042.

[0064] FIG. 4B discloses the catheter 30 in a tubular shape when the adjustment mechanism is in the second state. The user retracts the flexible portion 306 (eg, flexible arm) for easy insertion or removal of the catheter 30. When catheter 30 is in tubular form, biasing element 3088 within compartment 3092 is compressed to its minimum length and defined as being in a second state. The compressed biasing element 3088 can induce the first valve mechanism 3082 to reliably block the inlet 3042.

[0065] FIG. 4C discloses the catheter 30 with the first valve mechanism 3082 open when the biasing element 3088 is not in the first or second state. When the user needs to open the first valve mechanism 3082 to drain body fluids, the user simply pulls on the control wire 310 to disconnect the first valve mechanism 3082 from the sheath 3048. At the same time, the diameter of the cage formed by flexible portion 306 is increased to provide higher fixation capacity.

[0066] The present disclosure further provides non-implantable catheters. As shown in FIG. 5, non-implantable catheter 40 has an elongated second portion 404 such that a portion of second portion 404 extends outside the subject's body when catheter 40 is inserted. Exists. FIG. 6 discloses the detailed structure of the non-implantable catheter 40. As shown in FIG. 6A, the catheter 40 includes a locking module within a compartment 4092 of the first portion 402 as well as an elongated second portion 404 and a locking module at the end of the connecting wire 4090 remote from the first valve mechanism 4082. It includes a two-valve mechanism 4084 and a cylindrical block 4022 protruding from the end of the first portion 402 near the inlet 4042. Further, the locking module includes a plurality of teeth 4026 located on the inner wall of the first portion 402 and a locking gear 4024 connected to the end of the connecting wire 4090 and slidably housed within the compartment 4092. . Further, the plurality of teeth 2046 maintains the locking gear 4024 in multiple positions (eg, two different positions) to control the first valve mechanism 4082 and the second valve mechanism 4084. As shown in FIG. 6A, when the catheter 40 is in the normal state, the biasing element 4088 is in a first state having a maximum length and the locking gear 4024 is in a first position relative to the teeth 4026. When locking gear 4024 is in the first position, catheter 40 is properly inserted and maintained in that position as the flexible arm is expanded by biasing element 4088. Further, the first valve mechanism 4082 closes the inlet 4042 of the second portion 404 and the second valve mechanism 4084 closes the outlet 4044 of the second portion 404. In other words, no bodily fluids can flow into or out of the catheter 40. Note that when locking gear 4024 is in the first position, locking gear 4024 is secured by teeth 4026.

[0067] As shown in FIG. 6B, the user retracts the flexible arms to place catheter 40 in a tubular shape for easy insertion or removal. At this time, biasing element 4088 is in a second state and compressed, causing locking gear 4024 to move to a second position relative to teeth 4026. Furthermore, the inlet 4042 and outlet 4044 of the second portion 404 are closed, and the locking gear 4024 is fixed in the second position by teeth 4026. In other words, catheter 40 maintains its tubular shape when the operator moves locking gear 4024 to the second position. Note that catheter 40 is easily removable from the subject's body when locking gear 4024 is in the second position. Locking gear 4024 prevents catheter 40 from inadvertently changing into a tubular shape that can be easily removed from the subject's body. Here, as shown in FIG. 6A, the strength of the biasing element 4088 in this embodiment is specifically configured such that the flexible portion does not easily retract. In particular, biasing element 4088 is designed to maintain when relatively large forces are applied to second portion 404 . These retention forces ensure that the flexible portion 406 remains in its cage shape and is not deformed by reaction forces from the surrounding muscles of the urethra. Only when locking gear 4024 is in the second position is catheter 40 in its tubular shape. That is, the locking module (i.e., teeth 4026 and locking gear 4024) is used to switch the catheter 40 between different configurations/states to prevent the user from accidentally removing the catheter in an undesired manner or at an undesired time. prevent.

[0068] Further, FIG. 6C shows an intermediate state of the catheter 40 between the tube shape/state (as shown in FIG. 6B) and the normal state (as shown in FIG. 6A). As shown in FIG. 6C, when a user adjusts second valve mechanism 4084 to move cylindrical block 4022 to engage inlet 4042, biasing element 4088 is compressed and locking gear 4024 engages teeth 4026. On the other hand, it is moved to the third position. Note that locking gear 4024 is not secured in the third position (as opposed to in its first and second positions) by teeth 4026. In other words, FIG. 6C shows that the catheter 40 is activated while the locking gear 4024 is in both the first position (as shown in FIG. 6A) or the second position (as shown in FIG. 6B). is intended. In particular, in the actuation of FIG. 6C, the user applies force to the second valve mechanism 4084. Depending on its starting condition, the catheter 40 changes from FIG. 6A to FIG. 6C and then to FIG. 6B, or from FIG. 6B to FIG. 6C and then to FIG. 6A. The actuation in FIG. 6C switches catheter 40 such that it is (or is not) easily removable from the subject's body. As shown in FIG. 6C, the above-described actuation is accomplished by the restoring force of the biasing element 4088 in response to the operator applying and then releasing a force on the second valve mechanism 4084.

[0069] It should be noted that conventional catheters with elongated tubes have the problem of urine remaining within the tube. The dual valve mechanism and locking module of catheter 40 solves these problems. As shown in FIG. 6C, when the user pulls the second valve mechanism 4084 to place the catheter 40 in the intermediate state, the first valve mechanism 4082 and the second valve mechanism 4084 are disconnected from the inlet 4042 and outlet 4044, respectively; Cylindrical block 4022 positively engages inlet 4042 and closes recess 4042 . In other words, inlet 4042 is closed but outlet 4044 is open. Therefore, urine within passageway 4046 can be completely drained. As a result, the problem of urine remaining within the catheter itself can be better avoided.

[0070] FIG. 6D illustrates the use of catheter 40 to drain body fluid (eg, urine) within a body cavity (eg, bladder) when catheter 40 is in its normal state/configuration. As shown in FIG. 6D, when the user needs to urinate, the user simply pulls the second valve mechanism 4084 to slightly move the locking gear 4024 away from the first position; Without moving to the third position, the biasing element 4088 is further compressed. Accordingly, both the inlet 4042 and the outlet 4044 are open, allowing body fluid to drain through the second portion 404 of the catheter 40. Now, when the user releases the second valve mechanism 4084, the catheter 40 returns to its normal state (as shown in FIG. 6A) due to the restoring force of the biasing element 4088 (i.e., the locking gear 4024 fixed in the first position). In other words, the amount of force applied by the user in Figure 6D (to expel urine within the body cavity) is less than the force in Figure 6C (to expel urine remaining in the catheter). The force applied during actuation of FIG. 6C must be substantial to switch locking gear 4024 between the first and second positions. On the other hand, the forces applied in the actuation of FIG. 6D are not intended to achieve the described actuation. That is, it is intended only for the user to drain urine from a body cavity, as opposed to switching the catheter 40 into a state where it can be easily removed from the subject's body.

[0071] Additionally, because catheter 40 is a non-implantable catheter, a preferred length of second portion 404 of catheter 40 is approximately 15 cm to 20 cm. To achieve the above-mentioned functions, the catheter of the present disclosure can be formed from polyvinyl chloride (PVC), silicone , thermoplastic polyurethane (TPU), thermoplastic rubber (TPR), or any combination thereof. .

10, 20, 30, 40 Catheter 50 Bladder 51 Urethra 52 Prostate 53 External urethral sphincter 54 Corpus cavernosa 55 Urine 102, 202, 302, 402 First portion 104, 204, 404 Second portion 106, 206, 306, 406 Flexible sexual portion 108, 208 adjustment mechanism 112, 212 withdrawal wire 210, 310 control wire 1042, 2042, 3042, 4042 inlet 1044, 2044, 4044 outlet 1046, 2046, 4046 passageway 1048, 2048, 3048 sheath 1084, 2084 first end 1086 Second end 2082, 3082, 4082 First valve mechanism 3088, 4088 Biasing element 3090, 4090 Connection wire 3092, 4092 Section 4022 Cylindrical block 4024 Locking gear 4026 Teeth 4084 Second valve mechanism

Claims (20)

A catheter for guiding body fluids of a subject, the catheter comprising:
an elongate body having a proximal tip and a distal tip, the elongate body further comprising a first portion, a second portion, and a flexible portion between the first portion and the second portion. an elongated body, the second portion including a peripheral wall defining a passageway for the body fluid, the passageway further including an inlet and an outlet;
an adjustment mechanism having two opposite ends, a first end of the adjustment mechanism engaging the first portion and a second end of the adjustment mechanism engaging the first portion proximal to the entrance of the passageway; an adjustment mechanism removably engaged to the second portion, the adjustment mechanism being adapted to change between different states;
The adjustment mechanism is in a first state to secure the catheter within the subject when the flexible portion is expanded, and the adjustment mechanism changes to a second state when the flexible portion is retracted. to enable insertion of the catheter into or removal of the catheter from the subject;
the body fluid is directed to enter the passageway via the inlet of the second portion and exit via the outlet of the second portion;
the first part and the second part are arranged coaxially,
The adjustment mechanism is removably connected to the inlet of the second portion through axial movement of the adjustment mechanism . 2. The first portion of the elongate body further comprises a compartment, and the adjustment mechanism further comprises a biasing element proximate the first end, the biasing element being housed within the compartment. Catheter described. 3. The catheter of claim 2, wherein the biasing element is compressed in the second state. The catheter of claim 1, wherein the adjustment mechanism is extended in the second state. The catheter of claim 1, wherein the second end of the adjustment mechanism does not obstruct the passageway. 5. The catheter further comprises a withdrawal wire connected to the second portion, the withdrawal wire adapted to extend outside the subject to facilitate removal of the catheter. 1. The catheter according to 1. The catheter of claim 1, wherein the second portion has a length of about 4 cm to 6 cm. the second end of the regulating mechanism includes a first valve mechanism proximal to the inlet of the passageway, the body fluid entering the passageway through the inlet when the first valve mechanism is opened; The catheter of claim 1, wherein the body fluid is prevented from entering the passageway when the first valve mechanism is closed. 9. The first portion of the elongated body further comprises a compartment, and the adjustment mechanism further comprises a biasing element near the first end, the biasing element being housed within the compartment. Catheter described. The catheter of claim 8, wherein the second portion has a length of about 7 cm to 10 cm. A catheter for guiding body fluids of a subject, the catheter comprising:
an elongate body having a proximal tip and a distal tip, the elongate body further comprising a first portion, a second portion, and a flexible portion between the first portion and the second portion. an elongated body, the second portion including a peripheral wall defining a passageway for the body fluid, the passageway further including an inlet and an outlet;
an adjustment mechanism having two opposite ends, a first end of the adjustment mechanism engaging the first portion and a second end of the adjustment mechanism engaging the first portion proximal to the entrance of the passageway; an adjustment mechanism removably engaged to the second portion, the adjustment mechanism being adapted to change between different states;
The adjustment mechanism is in a first state to secure the catheter within the subject when the flexible portion is expanded, and the adjustment mechanism changes to a second state when the flexible portion is retracted. to enable insertion of the catheter into or removal of the catheter from the subject;
the body fluid is directed to enter the passageway via the inlet of the second portion and exit via the outlet of the second portion;
the second end of the regulating mechanism includes a first valve mechanism proximal to the inlet of the passageway, the body fluid entering the passageway through the inlet when the first valve mechanism is opened; the body fluid is prevented from entering the passageway when the first valve mechanism is closed;
The adjustment mechanism comprises a control wire configured to open or close the first valve mechanism. The flexible portion expands when the control wire is pulled to open the first valve mechanism such that the flexible portion and the first portion are more securely secured within the subject. The catheter according to item 11. The catheter is
a locking module housed within the first portion and engaging the adjustment mechanism;
further comprising a second valve mechanism at the distal end of the control wire for controlling the evacuation of the body fluid from the passageway through the outlet;
12. The catheter of claim 11, wherein the locking module controls opening and closing of the inlet when the adjustment mechanism is not in the second state. 14. The catheter of claim 13, wherein the second portion has a length of about 15 cm to 20 cm. 14. The catheter of claim 13, wherein the outlet of the passageway is external to the subject. The catheter of claim 1, wherein the flexible portion comprises at least two arms. 2. The catheter of claim 1, wherein the catheter material comprises polyvinyl chloride (PVC), silicone, thermoplastic polyurethane (TPU), thermoplastic rubber (TPR), or any combination thereof. 2. The catheter of claim 1, wherein the first portion and the flexible portion are disposed within a tubular or pouch-like organ of the subject when the catheter is not in the second state. 19. The catheter of claim 18, wherein the tubular or sac-like organ is defined by the bladder. A catheter for guiding body fluids of a subject, the catheter comprising:
an elongate body having a proximal tip and a distal tip, the elongate body further comprising a first portion, a second portion, and a flexible portion between the first portion and the second portion. an elongated body, the second portion including a peripheral wall defining a passageway for the body fluid, the passageway further including an inlet and an outlet;
an adjustment mechanism having two opposite ends, a first end of the adjustment mechanism engaging the first portion, a first valve mechanism configured at a second end of the adjustment mechanism; A valve mechanism is removably engaged with the second portion proximal to the inlet of the passageway, and the body fluid can enter the passageway through the inlet when the first valve mechanism is opened. an adjustment mechanism, wherein the body fluid is prevented from entering the passageway when the first valve mechanism is closed;
The adjustment mechanism is in a first state to secure the catheter within the subject when the flexible portion is expanded, and the adjustment mechanism changes to a second state when the flexible portion is retracted. to enable insertion of the catheter into/removal of the catheter from the subject;
the body fluid is directed to enter the passageway via the inlet of the second portion and exit via the outlet of the second portion;
the first part and the second part are arranged coaxially,
The adjustment mechanism is removably connected to the inlet of the second portion through axial movement of the adjustment mechanism .

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